Cleared Traditional

K092479 - SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL

K092479 is an FDA 510(k) clearance for SDX-SPIRODYNR'X RADIOTHERAPY BREATHING ..., manufactured by Dyn'R. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K092479 · Dyn'R · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
151d
Days
Class 2
Risk

K092479 is an FDA 510(k) clearance for the SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Dyn'R (Muret, FR). The FDA issued a Cleared decision on January 11, 2010 after a review of 151 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K092479

510(k) Number K092479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2009
Decision Date January 11, 2010
Days to Decision 151 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 107d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

All 716
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K092479.
P-ART, MODEL 001
K092424 · P-Cure, Ltd. · Mar 2010
FLEXIMARC, MODEL CM-0.9-2-10-GG-L
K100267 · Cortex Manufacturing, Inc. · Feb 2010
RESPISENS
K092845 · Nomics · Jan 2010
TIGRT IVS
K092550 · Linatech, LLC · Dec 2009
ARIA RADIATION ONCOLOGY WITH MIRS
K093527 · Varian Medical Systems, Inc. · Dec 2009
TRILOGY MX
K092871 · Varian Medical Systems, Inc. · Nov 2009
K092479 · SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL
Download PDF FDA Summary Dyn'R